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Risk Assessment generated by a regulatory process (RA)
last updated: 19 Feb 2021
Determination for the Safety Assessment of Combined Trait Product CORN MON87427 x MON89034 x MIR162 x NK603 for Direct Use as Food, Feed and for Processing
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- Competent National Authority: | BCH-CNA-PH-46524-5 This document has been updated. This is not the latest published version. Click here to view the latest version of the record.Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: +632 920-3986, +632 924-1278 local 2802,Fax: +632 920-3986,Email: osec.da@gmail.com,Website: http://www.da.gov.ph,
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MON-87427-7 × MON-89Ø34-3 × SYN-IR162-4 × MON-ØØ6Ø3-6 - Insect resistant Herbicide tolerant Corn| Monsanto | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glyphosate)
MON87427 x MON89034 x MIR 162 x NK603 maize combines two Bt proteins named Cry1A.105 and Cry2Ab2. These proteins, also called Bt-toxins are proven to be safe, however the potential of non-target effects of Bt toxins, including alternative modes of action for Cry toxins have been addressed previously.
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The protein products (CP4 EPSPS, Cry1A.105, Cry2Ab2, Vip3Aa20, and PMI) have different modes of action and belong to different metabolic reactions. In addition, there is no known mechanism of interaction of the protein products. Therefore they are not expected to interact in the stacked hybrid; hence, no new allergen and toxin could be produced. CP4 EPSPS and Cry2Ab2 are expected to accumulate in the chloroplast while Cry1A.105, Vip3Aa20 and PMI are expected to accumulate in the cytoplasm.
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The mode of action is different for each gene product. They have individual roles, different specificities and do not share same targets or substrates. Genetic and molecular analyses showed that all genes are inherited, expressed and functioning properly in MON 87427 x MON 89034 x MIR 162 x NK 603, as they did similarly in single events.
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The expression of the proteins in maize plant tissue from stacked MON 87427 x MON 89034 x MIR162 x NK603, MON 87427, MON 89034, MIR162 and NK603 is similar to the corresponding levels in single events based on ELISA. Results showed that the proteins are expressed properly to the combined trait product as in its relevant single events.
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Corn MON87427 x MON89034 x MIR162 x NK603 will not pose any significant risk to the health and environment and that any hazards could be managed by the measures set by the department. A biosafety permit for direct use can be issued for the said event.
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Corn MON87427 x MON89034 x MIR162 x NK603 has no evidence of interaction on the resulting gene products.
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This application is not for propagation of the combined trait product corn MON87427 x MON89034 x MIR162 x NK603. This LMO will be directly used for food, feed and for processing.
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Diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR methods may be used.
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Combined trait product corn MON87427 x MON89034 x MIR162 x NK603 is intended for direct use as food, feed and for processing.
All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of this combined trait product.
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All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of this combined trait product.
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